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FDA Clearance

Eyenuk Raises $26M for AI-Powered Eye Screening & Predictive Biomarkers

by Syed Hamza Sohail 10/17/2022 Leave a Comment

Eyenuk Raises $26M for AI-Powered Eye Screening & Predictive Biomarkers

What You Should Know: - Eyenuk, Inc., a global artificial intelligence (AI) digital health company and the leader in real-world applications for AI Eye Screening™ and AI Predictive Biomarkers™, today announced it has secured $26 million in a Series A financing round, bringing the Company’s total funding to over $43 million. - The capital raise was led by AXA IM Alts and was joined by new and existing investors including T&W Medical A/S, A&C Foelsgaard Alternativer ApS, Kendall
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Optellum Raises $14M for AI-Enabled Lung Cancer Diagnosis

by Fred Pennic 09/27/2022 Leave a Comment

Optellum Raises $14M for AI-Enabled Lung Cancer Diagnosis

What You Should Know: - Optellum, an Oxford-based digital health company that provides a breakthrough AI platform to diagnose and treat early-stage lung cancer raises $14M in Series A funding led by Mercia, with additional investors Intuitive Ventures and Black Opal Ventures. Existing investors, including St John's College in the University of Oxford, IQ Capital, and the family office of Sir Martin & Lady Audrey Wood, also participated in this round. - The investment will enable
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Assisted Polyp Detection Device Receives FDA Clearance

by Syed Hamza Sohail 09/22/2022 Leave a Comment

AI-Assisted Polyp Detection Device Receives FDA Clearance

What You Should Know: - Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced recently that SKOUT™ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance. - The device was evaluated in the largest U.S.-based multicenter clinical study for a
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Eko Lands $2.7M NIH Grant to Train Pulmonary Hypertension AI

by Syed Hamza Sohail 09/20/2022 Leave a Comment

Eko Lands $2.2M NIH Grant to Train Pulmonary Hypertension AI

What You Should Know: - Eko, a digital health company applying machine learning in the fight against heart and lung disease, today announced that it was awarded a $2.7M Small Business Innovation Research (SBIR) Direct Phase II grant by the National Institutes of Health’s (NIH) Department of Health and Human Services (HHS). - The grant will fund the development of a machine learning algorithm that detects and stratifies pulmonary hypertension (PH) using phonocardiogram (PCG) and
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RapidAI Awarded FDA Clearance for AI-Powered CT Scans to Identify Intracerebral Hemorrhage

by Syed Hamza Sohail 07/21/2022 Leave a Comment

RapidAI Awarded FDA Clearance for AI Powered CT Scans to Identify Intracerebral Hemorrhage

What You Should Know: - RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity, the newest addition to the RapidAI platform. - The tool empowers physicians to quickly assess the severity of injury in patients with acute neuro conditions such as traumatic brain injury and brain hemorrhages – allowing for better and faster patient care decisions. AI Powered
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FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics

by Fred Pennic 07/12/2022 Leave a Comment

FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics

What You Should Know: - Today, Eko, a digital health company advancing heart and lung disease detection, has announced the FDA has issued clearance for its Eko Murmur Analysis Software (EMAS), the first and only machine learning algorithm to screen for valvular heart disease (VHD). - The next generation of Eko’s murmur detection capabilities grants Eko the first and only smart stethoscope on the market that can identify and
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Fitbit Receives FDA Clearance for New PPG Algorithm to Identify AFib

by Fred Pennic 04/12/2022 Leave a Comment

Fitbit Receives FDA Clearance for New PPG Algorithm to Identify AFib

What You Should Know: - Fitbit announced it has received clearance from the FDA for its PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally.  - The algorithm will soon be available to users in the U.S. through Fitbit’s new Irregular Heart Rhythm Notifications feature on eligible heart-rate tracking devices.
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Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App

by Jasmine Pennic 04/08/2022 Leave a Comment

Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App

What You Should Know: - Arterys, the world's leading vendor-neutral artificial intelligence (AI) platform, has announced several new modules to its already robust Cardio AI clinical application and an additional FDA AI clearance based on deep learning.  - Cardio AI is a comprehensive, cloud-based post-processing solution that leverages AI and deep learning to provide extremely accurate, automated, fast, repeatable analysis of cardiac MRI images. Cardio AI: AI-Assisted Cardiac MRI
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Precision Medicine Startup Prenosis Raises $20M for Acute Care Solutions, Starting with Sepsis

by Jasmine Pennic 03/10/2022 Leave a Comment

Precision Medicine Startup Prenosis Raises $20M for Acute Care Solutions, Starting with Sepsis

What You Should Know: - Prenosis, Inc., a precision medicine company, announced a venture investment from PACE Healthcare Capital, an early-stage investment firm committed to improving health outcomes. This investment brings total funding in the company to over $20 million, including partnerships with Foxconn, Roche Diagnostics, the Defense Threat Reduction Agency, and others.   - Precision medicine company will use the funding to
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MediView XR Secures $9.9M for Augmented Reality Surgical Navigation Platform

by Fred Pennic 03/09/2022 Leave a Comment

MediView XR Secures $9.9M for Augmented Reality Surgical Navigation Platform

What You Should Know: - MediView XR, Inc., raises $9.9M in SAFE financing syndicated by Inside View Investments, LLC, a private investment firm.  MediView has raised approximately $14.4MM in total funding to date. - Investment will support key technology development, commercialization and regulatory submissions. MediView XR Inc., a Cleveland-based medtech company that leverages augmented reality, remote connectivity and spatial computing data to create revolutionary surgical
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